Steroids and Cross-linking for Ulcer Treatment
Keratitis BacterialSteroids and Cross-linking for Ulcer Treatment (SCUT II) is an international, randomized, double-masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (CXL), as well as to further evaluate findings from subgroup analyses of SCUT. Patients presenting to the Aravind Eye Care System (India), Kaiser Permanente Northern California (USA), or the University of California, San Francisco (USA) with smear-positive and/or culture-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups: Group 1: Standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham CXL Group 3: CXL plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus CXL
Wharton's Jelly Eye Drops in the Treatment of Chronic Keratitis
KeratitisUlcerative1 moreThe purpose of this open, non-comparative, multicenter trial is to assess the impact of eye drops made of Wharton's jelly extract in the treatment of chronic keratitis that failed available therapies.
Safety and Effectiveness of the PXL Platinum 330 System With Riboflavin Solution for Refractory...
KeratitisCorneal UlcerThis study is being conducted to evaluate the safety and effectiveness of using the PXL Platinum 330 System with riboflavin solution for performing corneal collagen crosslinking (CXL) for the treatment of refractory corneal ulcers. The PXL Platinum 330 System is a combination product consisting of an ultraviolet-A (UV-A) 365 nm wavelength light source (PXL Platinum 330 Illumination System) and riboflavin (Peschke Riboflavin 0.25% Transepithelial Solution) administered in conjunction with the UV-A light as a photosensitizer. The PXL Platinum 330 System is intended to induce corneal collagen CXL to improve the biomechanical properties of the cornea by strengthening the corneal tissue in the anterior stroma. Corneal collagen CXL is performed by pretreating the cornea with riboflavin 0.25% ophthalmic solution beginning 40 min before UV-A light exposure to saturate the corneal tissue with the riboflavin photosensitizer. The cornea is then irradiated with UV-A light (365 nm) at an irradiance of 18 mW/cm2 (5 seconds on, 5 seconds off) for 10 min. Exposure of the cornea to this UV-A light regimen after topical administration of riboflavin (0.25%) has been shown to induce CXL of the corneal collagen fibrils, with a resultant increase in tensile strength and diameter of the collagen fibrils. Clinically, CXL has been shown to stabilize the corneal curvature in eyes with progressive keratoconus, with no significant change in the refractive index of the cornea. Numerous reports and a few clinical trials have also shown benefit in aiding resolution of infective corneal ulcers.
Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis
KeratitisUlcerative3 moreThis clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Acanthamoeba KeratitisFungal KeratitisRose Bengal Electromagnetic Activation with Green light for Infection Reduction (REAGIR ) is an international, randomized, doubled masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT). Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with either smear or culture positive fungal or acanthamoeba keratitis or smear and culture negative corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups: Group 4, Sham RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus sham RB-PDT Group 5, RB-PDT: topical chlorhexidine gluconate 0.02% (acanthamoeba), moxifloxacin 0.5% (smear/culture negative) or natamycin 5% (fungal keratitis) plus RB-PDT.
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Collagen Cross-Linking in Eyes...
KeratoconusUnstable2 moreTo determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.
3 Month Study of Alocross Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis...
Dry Eye SyndromesThis study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is conducted at a national level, in France. The patients will be randomised to receive ALOCROSS® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis...
Neurotrophic KeratitisThis study will enroll subjects with stage 2 or 3 neurotrophic keratitis. Subjects will be randomized in a 1:1 ratio to the CSB-001 investigational treatment arm or vehicle control arm. All subjects will dose with the randomized treatment four times daily for 8 weeks (controlled treatment phase). During the controlled treatment phase, subjects will return to the clinic weekly from Day 0 to Week 8, and again at Week 10. Subjects randomized to the vehicle arm who are not healed will have the opportunity to participate in an open-label uncontrolled treatment phase.
Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking in Eyes...
KeratoconusUnstable2 moreTo determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.
Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.
Neurotrophic KeratitisMany diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. This study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.